Who will be the next Medtronic? What will be Minnesota's next breakthrough industry? James Walsh will provide the latest information and commentary on the people, companies and trends driving innovation in Minnesota. From visionary entrepreneurs to game changing technologies, this blog offers a window into the future of Minnesota's economy.

Posts about Minnesota innovation

2014 Medtronic Global Heroes applications sought

Posted by: James Walsh Updated: March 10, 2014 - 3:49 PM

Are you a distance runner who has benefitted from medical technology? Medtronic wants you… to run as a Global Hero.

Once again, the Fridley-based medical technology giant is sponsoring its Global Heroes team and will select up to 25 runners, who will receive a paid entry for themselves and a guest to the Medtronic Twin Cities Marathon or the Medtronic TC 10 Mile. They will also receive airfare and accommodations for the Global Hero and a guest.

The 2014 Medtronic Twin Cities Marathon weekend will take place October 3-5, 2014.  Since 2006, 184 runners representing 27 different countries and a myriad of chronic and degenerative disease conditions have run the beautiful course that winds through the lakes and neighborhoods of Minneapolis and St. Paul.

Applications and information for the 2014 Medtronic Global Hero team are available at medtronic.com/globalheroes.  The application deadline is April 25, 2014.

To qualify as a Global Hero, runners must currently be using a medical device therapy to treat the following disease categories: heart disease, diabetes, chronic pain, spinal disorders, or neurological, gastroenterology and urological disorders. Eligible medical devices include any pacemaker or implantable cardioverter defibrillator (ICD), any spinal device, any neurological device, any insulin pump, or any heart valve. The device does not have to have been made by Medtronic.

Runners will be chosen by a committee of Twin Cities In Motion. Certain conditions may apply and applicants must certify that they have discussed race participation with their physician.

Mercy Hospital first to use new FFR technology by Eden Prairie company

Posted by: James Walsh Updated: February 19, 2014 - 11:34 AM

ACIST Medical Systems of Eden Prairie on Wednesday announced the first successful human case to use its RXi Rapid Exchange FFR System in the United States.

Dr. Jeff Chambers of Metropolitan Heart and Vascular Institute in Coon Rapids performed the Fractional Flow Reserve (FFR) procedure on Monday. FFR is used to detect and assess blockages in coronary arteries that could require angioplasty.

The new technology was designed to provide physicians with a faster and easier way to perform FFR procedures, ACIST said in a statement.

“The ACIST Rapid FFR System offers a significant step forward in diagnostic assessment,” said Chambers, an interventional cardiologist and the director of the Cardiac Catheterization Lab at Mercy Hospital. “With Rapid FFR, measurements can be obtained quickly and easily without disrupting cath lab workflow… The time savings and ease of use are significant advantages, especially in complex coronary interventions like the ones we routinely perform here at Mercy."

Tom Morizio, president and chief operating officer of ACIST, said: “The RXi Rapid Exchange FFR System is a major step forward in the transformation of ACIST…. The technology in the RXi Rapid Exchange FFR System will continue to evolve and advance our mission to simplify the complexities in the Cath Lab.”

ACIST received FDA clearance for the RXi system in January. The company conducted a clinical trial in New Zealand and is currently performing an additional study in Europe. ACIST is moving forward with a limited market rollout of the system in advance of a full global release in the spring of 2014.  For more information about ACIST, go to: www.acist.com.

Medtronic announces European launch of system to treat lower extremity blockages

Posted by: James Walsh Updated: February 13, 2014 - 11:10 AM

Medtronic on Thursday announced the European launch of its Total Across crossing catheter, angioplasty balloon technology that treats blockages and narrowing of the arteries in the lower extremities.

The Total system also treats blockages in below-the-knee blood vessels, Medtronic said.

Fridley-based Medtronic’s system recently received CE Mark approval for sale in Europe and other markets. The company also has submitted an application to the U.S. Food and Drug Administration for clearance. The FDA has not yet approved the Total Across catheter for sale in the United States.

Dr. Andrej Schmidt, an angiologist and cardiologist at the Center for Vascular Medicine at Park-Hospital Leipzig, Germany, is among the first European physicians to use the device. He called it “a tangible step forward in microcatheter design, providing extraordinary support and stability.”

Tony Semedo, a Medtronic senior vice president and president of its Endovascular Therapies business, said: “The Total Across crossing catheter expands our portfolio of medical devices for the interventional treatment of peripheral artery disease.  It's a prime example of our focus on developing lesion-specific solutions and our ongoing commitment to addressing BTK lesions specifically. We are excited to be introducing this new device in Europe and look forward to bringing it to the United States in the near future."

Medtronic said the Total Across crossing catheter is the first of three new products to address below-the-knee critical limb ischemia (CLI) that the company plans to introduce around the world over the next two years. CLI is a severe obstruction of the arteries that decreases blood flow to the arms, hands, legs and feet, progressing to the point of severe pain and even skin ulcers and sores.

Other devices in Medtronic's peripheral product portfolio aimed at treating lower-extremity disease include the Complete SE (self-expanding) vascular stent, the In.Pact line of drug-coated balloons and the Admiral, Pacific and Amphirion families of percutaneous transluminal angioplasty (PTA) balloon catheters. The Pacific and Amphirion PTA balloons are designed specifically for use in below-the-knee arteries, Medtronic said.

FDA approves Medtronic pacemaker for MRI... without scanning restrictions.

Posted by: James Walsh Updated: January 22, 2014 - 10:07 AM

Medtronic Inc. on Thursday announced that its SureScan pacing systems – the first and only pacing systems in the United States that have been approved by the U.S. Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI) – are now approved for MRI scans positioned on any region of the body. Previously, patients implanted with the devices could not have MRI scans of the chest area.

“This approval allows for a more streamlined MRI scanning process and makes scanning the chest easier and more accessible for patients with pacemakers,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Because MRI is the standard of care for soft tissue imaging and is a critical component for early detection, diagnosis and treatment, this FDA approval will help more patients with SureScan pacemakers receive the MRI scans they need.”

Generally, patients with pacemakers do not receive MRI scans because of the potential that the MRI machine could interfere with the device.

But Medtronic says that up to 75 percent of patients worldwide with implanted cardiac devices will need an MRI scan during the lifetime of their devices.

The FDA approved the first MRI compatible pacemaker available in the U.S. – Medtronic’s Revo MRI, in February 2011. A second generation pacemaker, the Advisa MRI, was approved by the FDA in January 2013.

Northfield med tech startup to begin large pivotal trial

Posted by: James Walsh Updated: January 14, 2014 - 11:24 AM

AUM Cardiovascular, an award-winning Minnesota medical technology startup, is sponsoring a major pivotal study to prove its non-invasive technology can detect obstructive coronary artery disease (CAD) just as well as a Single Photon Emission Computed Tomography (SPECT) nuclear stress test.

SPECT is the most common nuclear scanning test for diagnosing problems with blood flow to the heart.

AUM’s CADence system is a handheld device, used by a cardiologist, that can quickly spot blockages in blood vessels around the heart after just a few measurements. It uses an algorithm to detect changes in pressure within the blood vessels – changes that could indicate whether those arteries are clogged with plaque.

Marie Johnson, AUM CEO, said CADence is as accurate as a treadmill stress test. Now the study will attempt to prove it.

AUM’s clinical study will enroll 729 patients at 15 trial centers across the United States. Dr. Joseph Thomas, an Assistant Professor of Clinical Medicine at the UCLA David Geffen School of Medicine, will chair the study.

Founded in 2008, AUM Cardiovascular has raised over $5 million from angel investors. In competition against 1,000 companies, AUM won the 2011 Minnesota Cup, an annual statewide competition for promising startups. AUM was recently named one of the top 10 start-up companies in the world by the Innovations in Cardiovascular Intervention conference in Tel Aviv, Israel. The company is located in Northfield, MN.

For more information, go to aumcardio.com.


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